Trials / Completed
CompletedNCT02739100
Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Rockwell Medical Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triferic |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2016-04-14
- Last updated
- 2019-02-01
- Results posted
- 2019-02-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02739100. Inclusion in this directory is not an endorsement.